Effectiveness of Messages to Mobile Phone in Smoke Cessation
|ClinicalTrials.gov Identifier: NCT01746069|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : October 21, 2015
Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking.
Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients.
Methods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale.
Sample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients.
Control group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test).
Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: Quit smoking combined cessation programme Behavioral: health advice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||October 2015|
Placebo Comparator: health advice
clinical practice routine
Behavioral: health advice
routine clinical practice
Experimental: Quit smoking combined cessation programme
Health advice and support sms messages to patient's mobile phone + clinical routine practice
Behavioral: Quit smoking combined cessation programme
Support sms messages to patient's mobile phone and health advice
- Coximetry test (positive/negative) [ Time Frame: at 6 months ]
- Continuous abstinence at 6 months: Yes / No [ Time Frame: At 6 months ]Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient.
- Abstinence point during the first 7 days self-reported by the patient: Yes / No. [ Time Frame: at first week ]Abstinence is defined as not smoking anything punctual during the last seven days.
- -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No. [ Time Frame: At 4th week ]
- -Prevalence abstinence at 12th week self-reported by the patient: Yes / No. [ Time Frame: At 12th week ]
- -Outcome of coxymetry test at 12 months of start: Positive / Negative. [ Time Frame: at 12 months ]Only in patients with a negative result in the 6 months test
- Number of messages requested by the patient anxiety. [ Time Frame: at 12 months ]
- slip: Yes / No. [ Time Frame: at 12 months ]Treated as the first use (consumption point) after a period of abstinence
- - Relapse: Yes / No. [ Time Frame: At 12 months ]Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.
- Number of messages relapse-slip timely requested by the patient. [ Time Frame: At 12 months ]
- other variables [ Time Frame: at baseline ]Sex (male / female), age (years), number of cigarettes per day before starting program, age of start smoking (years), smoke related pathology (Yes/No), score on the anxiety scale Goldberg, previous attempts to quit smoking (Yes / No if yes, specify number of attempts and reasons for relapse), ), smoking dependence fagerström test score), type of smoker (occasional / daily).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746069
|Health centre Lakuabizkarra|
|Vitoria-Gasteiz, Alava, Spain, 01009|